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www.fdanews.com/articles/176983-astute-medical-gains-fda-clearance-for-nephrocheck-test

Astute Medical Gains FDA Clearance for NephroCheck Test

June 9, 2016

Astute Medical has secured FDA clearance for updates to its NephroCheck test kit, which is intended for the risk assessment for moderate or severe acute kidney injury.

The clearance prolongs the shelf life for the test to 12 months when refrigerated.

The test, which is intended to be used in combination with clinical evaluation, can determine AKI risk within 12 hours post administration. — Anisa Jibrell

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